MENTOR MemoryGel Xtra Breast Implant SMHX500Recalls & reported problems
Mentor Texas L.P. · Smooth Moderate High Profile Xtra, 500 cc |Smooth|Round|Silicone| · Class 3 · Implant
All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel Xtra Breast Implant (88)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Mentor MemoryGel Xtra silicone breast implant, smooth round moderate-plus profile in a 500 cc size. The 49 reports mostly describe the scar tissue tightening around the implant (capsular contracture) that can make breasts hard, painful or misshapen, along with implant rupture, the implant shifting position, and swelling or infection at the incision. Reports describe 47 injuries and no deaths. No recalls name this implant.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10081317027888), received between Jul 20, 2021 and Sep 10, 2026 — classified as 47 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem35
- Material Rupture9
- Migration5
- Appropriate Device Problem Term/Code Not Available1
- Material Deformation1
Patient problems
- Capsular Contracture30
- Deformity/ Disfigurement12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Clinical Signs, Symptoms or Conditions3
- Pocket Erosion2
- Post Operative Wound Infection2
- Impaired Healing1
- Seroma1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a 27-year-old female patient underwent primary breast augmentation with 470cc MENTOR MemoryGel Xtra Breast Implant on the left side, and with 500cc MENTOR MemoryGel Xtra Breast Implant on the right side and experienced bilateral Capsular Contracture; Baker Grade IV postoperatively; diagnosed after physical exam. The patient has consulted with the healthcare professional. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This MedWatch report is for the patient¿s right-sided device.
Patient problems: Capsular Contracture
MAUDE report 50716720 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE IV ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 24802478 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24626267 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 30-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3), IMPAIRED HEALING, AND EARLY ONSET SEROMA ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT HAD VISITED THE HEALTHCARE PROVIDER REGARDING A SWELLING ALONG THE RIGHT INFRAMAMMARY FOLD SCAR. THE FOLD SCAR WAS INTACT BUT THERE WAS MILD SWELLING ALONG THE LATERAL PORTION, AND THE SKIN SEEMED TO BE THINNING. THE HEALTHCARE PROVIDER ASPIRATED WITH A 18-GAUGE NEEDLE, AND 2 ML OF SEROUS CLEAR FLUID WAS ASPIRATED. THE INCISION THEN OPENED FURTHER. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Capsular Contracture; Impaired Healing; Seroma
MAUDE report 24457857 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED DEVICE EXTRUSION THROUGH THE OPENED POSTOPERATIVE WOUND ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT THE RIGHT IMPLANT EXPLANTATION ON (B)(6) 2023. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Pocket Erosion
MAUDE report 24305917 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24274262 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24274258 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 23697994 ↗InjuryNov 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23648820 ↗InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2-3 ON THE RIGHT AND BAKER GRADE 3-4 ON THE LEFT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 23373006 ↗InjuryJul 30, 2025Material Rupture; Migration; Material Rupture; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL IMPLANT DISPLACEMENT AND THE PATIENT DESIRED AN INCREASE IN SIZE/VOLUME OF THE LEFT SIDE TO MATCH THE RIGHT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL CAPSULORRHAPHY, UNILATERAL LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT, AND RIGHT-SIDED IMPLANT REMOVAL AND REIMPLANTATION (B)(6) 2025. FURTHERMORE, DURING THE SURGERY, A RUPTURED LEFT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE FINDINGS. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22665641 ↗InjuryMay 29, 2025Material Rupture; Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL XTRA, 500CC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED SILENT RUPTURE POST OPERATION. THE MRI EXAMINATION CONFIRMED THE RUPTURE. AS A RESULT, SHE SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 22107198 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL CAPSULAR CONTRACTURE OF THE BREASTS (BAKER GRADE RATINGS WERE NOT PROVIDED). A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Capsular Contracture
MAUDE report 21968685 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL CAPSULAR CONTRACTURE OF THE BREASTS (BAKER GRADE RATINGS WERE NOT PROVIDED). A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Capsular Contracture
MAUDE report 21968647 ↗InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA 500CC SILICONE PROSTHESIS HAS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADED III AND LEFT-SIDED ASYMMETRY POSTOPERATIVELY. THESE ISSUES WERE CONFIRMED THROUGH MAMMOGRAM AND A PATIENT SYMPTOM EXAMINATION. CONSEQUENTLY, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2025, WHICH INCLUDED A RIGHT-SIDED TOTAL CAPSULECTOMY, LEFT-SIDED PARTIAL CAPSULECTOMY, AND THE PLACEMENT OF OVERTAX MESH, ALONG WITH BILATERAL PROSTHESIS REPLACEMENTS. THE DETAILS OF THE REPLACEMENTS ARE AS FOLLOWS: LEFT REPLACEMENT: (B)(6)/SHPX535 AND RIGHT REPLACEMENT: (B)(6)/SHPX535. THIS REPORT SPECIFICALLY ADDRESSES THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 21587523 ↗InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA 500CC SILICONE PROSTHESIS HAS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADED III AND LEFT-SIDED ASYMMETRY POSTOPERATIVELY. THESE ISSUES WERE CONFIRMED THROUGH MAMMOGRAM AND A PATIENT SYMPTOM EXAMINATION. CONSEQUENTLY, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2025, WHICH INCLUDED A RIGHT-SIDED TOTAL CAPSULECTOMY, LEFT-SIDED PARTIAL CAPSULECTOMY, AND THE PLACEMENT OF OVERTAX MESH, ALONG WITH BILATERAL PROSTHESIS REPLACEMENTS. THE DETAILS OF THE REPLACEMENTS ARE AS FOLLOWS: LEFT REPLACEMENT: (B)(6)/ SHPX535 AND RIGHT REPLACEMENT: (B)(6)/ SHPX535. THIS REPORT SPECIFICALLY ADDRESSES THE LEFT SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 21587489 ↗InjuryMar 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 500 CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH COMPUTED TOMOGRAPHY AND A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT AND REPLACEMENT IS PLANNED FOR (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21582831 ↗InjuryMar 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A LEFT BREAST INFECTION AND A RUPTURED LEFT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL LEFT-SIDED BREAST IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2024. THE PATIENT IS SCHEDULED ANOTHER SURGERY AT A LATER DATE TO IMPLANT A NEW LEFT DEVICE AND EXCHANGE THE RIGHT DEVICE. NO ISSUES WERE REPORTED FOR THE RIGHT SIDE.
Patient problems: Post Operative Wound Infection
MAUDE report 21530599 ↗InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 500 CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 21047919 ↗MalfunctionNov 12, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED FOR A BREAST RECONSTRUCTION PROCEDURE AND A SMALL DEFECT ON THE SHELL OF THE IMPLANT WAS NOTICED WHEN THE PACKAGE WAS OPENED PRIOR TO PATIENT CONTACT. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663801 ↗InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON APPROXIMATELY (B)(6) 2025. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Capsular Contracture
MAUDE report 20218019 ↗InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 500CC HAS EXPERIENCED BREAST IMPLANT EXTRUSION THROUGH THE SKIN AND BREAST INFECTION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT THE LEFT IMPLANT EXPLANTATION ON (B)(6) 2024.
Patient problems: Pocket Erosion; Post Operative Wound Infection
MAUDE report 20214977 ↗InjuryAug 22, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT MALPOSITION, RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III), RIGHT BREAST DOG EAR, AND PALPABLE NODULE ON THE LATERAL ASPECT OF THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT LEFT BREAST LATERAL CAPSULORRHAPHY, RIGHT BREAST CAPSULOTOMY, PARTIAL CAPSULECTOMY, EXCISION OF RIGHT BREAST DOG EAR, AND BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (RIGHT) 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX595 LOT: 9981369 SN: (B)(6) AND (LEFT) 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX595 LOT: 9939512 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 20033615 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL XTRA, 500CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SILENT RUPTURE, AND RIGHT-SIDED ASYMMETRY ISSUE POSTOPERATIVE. THE RUPTURE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTOPEXY, AND BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER SHPX-650, SERIAL NUMBER (B)(6), RIGHT CATALOG NUMBER SHPX-650, SERIAL NUMBER (B)(6) ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19310297 ↗InjuryMay 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL XTRA, 500CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SILENT RUPTURE, AND RIGHT-SIDED ASYMMETRY ISSUE POSTOPERATIVE. THE RUPTURE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTOPEXY, AND BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER SHPX-650, SERIAL NUMBER (B)(6), RIGHT CATALOG NUMBER SHPX-650, SERIAL NUMBER (B)(6) ON APRIL 18, 2024. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19310289 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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